The BOSTON XO2 Gas Permeable Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, astigmatism, and presbyopia) in aphakic and notaphakic persons with non-diseased eyes.

The lens may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

The lens is also indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Device Description

BOSTON XO2 (hexafocon B) Rigid Gas Permeable Contact Lens material is a fluoro silicone acrylate copolymer rigid gas permeable contact lens material. The material is available in blue, ice blue, green, or violet, yellow and red tint. The lenses may contain an ultraviolet light absorber, Uvinul D-49 or MHB. The blue and ice blue tinted lenses contain the color additive D&C Green No. 6; the green tinted lenses contain the color additives D&C Green No. 6 and C.I. Solvent Yellow No. 18; the violet tinted lenses contain the color additive D&C Violet No. 2. the red tinted lenses contain the color additive D&C Red No. 17; and the yellow lenses contain the color additive C.I. Solvent Yellow No.18. All of those color additives are listed in the Code of Federal Regulations (21 CFR 74.3206).

AI/ML Overview

The provided document is a 510(k) summary for a contact lens, not an AI/ML medical device. Therefore, many of the requested categories in the prompt, such as "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Training set sample size," or "Ground truth for training set," are not applicable. I will extract the information that is relevant to the acceptance criteria and the study proving the device meets those criteria based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Outcome Desired	Reported Device Performance (Boston XO2)
Lens Material Compatibility	No significant changes to lens parameters after 30 cycles with various care regimens.	No significant changes to lens parameters after 30 complete cycles.
Total Extractable Substances (ISO 10340:1995(E))	Total extractable amount should be less than or comparable to the predicate device (Boston XO).	Total amount of material extracted was less than that extracted from Boston XO.
Extractable Color Additives and UV Blockers (ISO 10340:1995(E))	Results should be similar to those obtained from the predicate device (Boston XO).	Results are similar to those obtained when extracting Boston XO.
Cytotoxicity (ISO 10993-5)	Material should not induce cytotoxicity.	Material did not induce cytotoxicity (in-vitro assay using L-929 cell monolayer).
Ocular Irritation (ISO 10993-10)	Material should be considered a non-irritant.	Material is considered to be a non-irritant (in rabbit ocular tissue).
Systemic Toxicity (ISO 10993-11)	Test samples should meet test requirements (e.g., normal observations).	All observations of the mice were normal; test samples meet test requirements.
Bioburden and Shelf-Life (ISO 11987:1997)	Average bioburden levels should be within acceptable limits (< 100 cfu/lens) after 30 days.	Average bioburden levels were within the acceptable limit of < 100 cfu/lens after 30 days.
Clinical Safety (Adverse Events)	No major complications or adverse events.	No adverse events related to the BOSTON XO2 product; no major complications; no test eyes required medical treatment; no slit lamp findings greater than grade 2.
Clinical Efficacy (Vision)	Vision provided should be comparable to the predicate device (Boston XO).	Vision provided by BOSTON XO2 is the same as vision with BOSTON XO.
Clinical Efficacy (Lens Tolerance/Symptoms)	Ratings for comfort, end of day comfort, burning/stinging, irritation, itching, dryness, and redness should be at least as good as the predicate device (Boston XO).	BOSTON XO2 was at least as good as BOSTON XO overall and at all follow-up visits for these attributes.
Overall Clinical Performance	Satisfactory vision quality and clinical performance meeting expectations.	Investigators were satisfied with vision quality and clinical performance; subjects were successful wearing the lenses.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document does not specify a numerical sample size for the clinical study. It mentions a "controlled, multi-center clinical study."
Data Provenance: The clinical investigation was conducted in accordance with the United States FDA regulations (21 CFR Parts 50, 54, 56 and 812), ICH Good Clinical Practices, ISO 14155-2 and the Declaration of Helsinki. This suggests the data was collected clinically, likely within the United States or countries adhering to these standards. The study compared BOSTON XO2 (test device) to BOSTON XO (predicate device). It explicitly states it included "adapted GP contact lens wearers." It is a prospective clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not explicitly provided. The clinical study involved "investigators" who assessed patient outcomes, but their specific qualifications or the number involved are not detailed. Given the nature of a contact lens study, the assessment of safety and efficacy would typically be performed by ophthalmologists or optometrists.

4. Adjudication method

Not applicable for this type of device and study. Clinical endpoints were likely assessed by the treating/evaluating clinician.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

For non-clinical tests, the "ground truth" was established by objective laboratory measurements and adherence to ISO standards (e.g., extractable substances, cytotoxicity, irritation, systemic toxicity, bioburden).

For the clinical study, the "ground truth" for safety and efficacy was based on:

Clinical assessments: Observations by "investigators" (likely ophthalmologists/optometrists) regarding adverse events, slit lamp findings, and overall clinical performance.
Patient-reported outcomes/symptoms: Ratings for vision, comfort, irritation, dryness, etc., reported by the "adapted GP contact lens wearers."
Comparison to predicate device: The performance of BOSTON XO2 was compared against the known and accepted performance of the predicate device, BOSTON XO.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning. The non-clinical tests involved specific lens samples and animal subjects as described. The clinical study involved human subjects, but this is a test set, not a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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K071266

510(K) SUMMARY BOSTON XO2 (hexafocon B) Rigid Gas Permeable Contact Lenses for Daily Wear

AUG 15 2007

1. Applicant's Name and Address

Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609

Debra Ketchum 2. Contact Person Manager, Global Regulatory Affairs Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609 (585) 338-8638 debra.ketchum@bausch.com

ર્જ ldentification of Device

Common Name:	contact lens-rigid gas permeable (hydrophobic)
Trade Name:	Boston XO2 (hexafocon B) Daily Wear ContactLens
Classification:	Class II ophthalmic (21CFR 886.5916)
Device classification:	Class II (21 CFR 886.5916)
Product Codes:	HQD, MUW

Predicate Devices:

The predicate device, Boston XO (hexafocon A) was selected to address material use and design (aspheric, bifocal, toric, irregular corneas, and orthkeratology).

The BOSTON XO2 is substantially equivalent to the currently marketed BOSTON XO cleared in 510(k) Premarket Notification Nos. K000795 on May 26, 2006, K001960 on August 28, 2000, K053124 on January 30, 2006 and K011945 on September 12, 2001. The difference between the two devices is a change in the component ratios.

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K000795, K001960, K043124 and K011945: Boston XO (hexafocon A)
510(k)	Clearance Date	Device Description
K000795	5/26/2000	Boston XO RGP DailyWear Contact Lenses
K001960	8/28/2000	Boston XO RGP for DailyWear OrthokeratologyContact Lenses
K053124	1/30/2006	Boston XO, Boston EO,Boston ES RGP DailyWear Contact Lenses(Post Surgical)
K011945	9/12/2001	Boston RGP ContactLenses wet shipped andstored in Boston AdvanceComfort FormulaConditioning Solution upto 30 days.

Description of device 4.

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5. Intended use

BOSTON XO2 (hexafocon B) Gas Permeable Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with non-diseased eves.

BOSTON XO2 may be prescribed in otherwise non-diseased eves that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

BOSTON XO2 is also indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes. Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

6. Description of Safety and Substantial Equivalence

A series of non-clinical laboratory testing and clinical testing was performed to demonstrate the safety and effectiveness of the BOSTON XO2 contact lens material. A summary of results from the non-clinical and clinical tests is provided below.

6.1. Lens Compatibility/Cycling Study
The compatibility of BOSTON XO2 material with several GP contact lens care regimens was assessed in this study. A lens cvcling study was completed with each contact lens care regimen. Initial and final data were compared. There were no significant changes to lens parameters after 30 complete cycles.
6.2. Determination of Total Extractables Substances (ISO 10340:1995(E))
Total Extractables testing was conducted on three lots of BOSTON XO2. The total amount of material extracted from BOSTON XO2 was less than that extracted from BOSTON XO the predicate device.
6.3. Determination of Extractable Color Additives and UV Blockers in Boston XO2 Material (ISO 10340:1995(E))
Determination of Extractable color additives and UV blockers testing was conducted on Boston XO2 material. These results are similar to those obtained when extracting Boston XO, the predicate device.

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6.4. Cytotoxicity Study Using The ISO Agar Overlay Method (ISO 10993-5)
This in-vitro assay demonstrated the biocompatibility of this material. The test sample is placed on an agar surface directly overlaying a arowing L-929 cell monolayer to determine if the material induces a cvtopathic effect. The material did not induce cytotoxicity.
6.5. ISO Ocular Irritation Study (ISO 10993-10)
USP 0.9% Sodium Chloride Injection and sesame oil extracts of the Boston XO2 GP lens material was evaluated for the potential to produce an irritating effect on the ocular tissue of the rabbits. According to the criteria of the study protocol, the material is considered to be a nonirritant.
6.6. USP and ISO Systemic Toxicity Test (ISO 10993-11)
This study was designed to evaluate acute systemic toxicity of the BOSTON XO2 material extract following a single intravenous or intraperitoneal injection into mice. All observations of the mice were normal. The test samples meet the test requirements.
6.7. Bioburden of Lenses and Stability of Bioburden of Lenses Over time: Evaluation of the BOSTON XO2 material (ISO 11987:1997)
A 30-day shelf-life study for Boston XO2 lenses stored in Boston Advance Comfort Formula Conditioning Solution and Boston SIMPLUS Multi-Action solution was conducted. The average bioburden levels for BOSTON XO2 lenses stored in lens cases with Boston SIMPLUS Multi-Action Solution and Boston Advance Comfort Formula Conditioning Solution after 30 days were within the acceptable bioburden limit of < 100 cfullens.

Clinical data: 7.

The clinical investigation was conducted in accordance with the United States FDA regulations (21 CFR Parts 50, 54, 56 and 812), ICH Good Clinical Practices, ISO 14155-2 and the Declaration of Helsinki.

The objective of this controlled, multi-center clinical study was to evaluate the safety and efficacy of the BOSTON XO2 (hexafocon B) Gas Permeable (GP) contact lens compared to the BOSTON XO (hexafocon A) GP contact lens when worn by adapted GP contact lens wearers on a daily wear basis.

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Safety Conclusions:

The use of the BOSTON XO2 (hexafocon B) gas permeable contact lens was well tolerated. There were no adverse events related to the BOSTON XO2 product.

The results of this evaluation demonstrated that treatment with the BOSTON XO2 (hexafocon B) qas permeable contact lens is safe when used as directed.

Efficacy Conclusions:

The vision provided by the BOSTON XO2 (hexafocon B) contact lens is the same as vision with the BOSTON XO (hexafocon A) contact lens. Other Symptoms/Complaint measures associated with lens tolerance (Comfort, End of Day Comfort, Burning/Stinging Upon Insertion, Irritation, Itching, Dryness, and Redness) ratings demonstrated that the BOSTON XO2 lens was at least as good as the BOSTON XO, overall, and at all follow-up visits for these attributes.

Other symptoms/complaints measures associated with lens tolerance (Comfort, End of Day Comfort, Burning/Stinging Upon Insertion, Irritation, Itching, Dryness, and Redness) ratings demonstrated that the BOSTON XO2 article was at least as good as the BOSTON XO, Overall, and at all follow-up visits for these attributes.

Discussion and Overall Conclusions:

The results of this study demonstrated that there were no major complications associated with the use of the BOSTON XO2 (hexafocon B) GP contact lens. This was supported by the fact that there were no adverse events, no test eves required medical treatment and there were no slit lamp findings greater than grade 2.

Vision measures were acceptable for the BOSTON XO2 (hexafocon B) GP contact lenses and were generally similar to the BOSTON XO contact lens. Symptoms/Complaints for various performance attributes associated with lens tolerance were also similar.

Overall, the investigators were satisfied with the vision quality that their subjects were able to obtain, the clinical performance of the lens met their expectations, and their subjects were successful wearing the BOSTON XO2 (hexafocon B) GP contact lenses.

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Conclusions drawn from studies 8. Substantial Equivalence:

Information provided in this 510(k) establishes that the BOSTON XO2 GP Contact Lens is equivalent in optical, chemical, and physical properties of the predicate device and does not raise any questions of safety and effectiveness. The clinical evaluation demonstrated safe and effective lens performance and equivalence with the predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 15 2007

Bausch & Lomb, Inc. c/o Debra Ketchum Manager, Global Regulatory Affairs 1400 North Goodman Street Rochester NY 14609-3547

Re: K071266

Trade/Device Name: Boston XO2 (hexafocon B) Daily Wear Gas Permeable Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD, MUW Dated: July 19, 2007 Received: July 23, 2007

Dear Ms. Ketchum:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the each as 1976, the enactment date of the Medical Device Amendments, or to conninered prior to rialy 20, 2012 - 12:25 pm accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration, listing of general obtaturing province, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassined (600 as a votrols. Existing major regulations affecting your device can may or subject to back as assisted Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Dri bristian that your device complies with other requirements of the Act that I Dri has made a averal regulations administered by other Federal agencies. You must or any I cuena statuted and registments, including, but not limited to: registration and listing (21 Comply with an the 110 - 210 - 21 - 21 - 2011; good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Debra Ketchum

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egeland, MD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

1071266

510(k) Number (if known): __

Device Name:

Boston XO2 (hexafocon B)

Indication for Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
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Over-the-counter-use
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(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number	K071266
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Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.